PARTNER 3 Clinical Trial Additional Information

New TAVR trial for patients with severe aortic stenosis

As people are living longer, we are seeing an increasing number of patients 65 and older with severe aortic stenosis (AS), a narrowing of the main valve that carries blood from the heart to the rest of the body. People with AS typically have no symptoms until the disease has progressed and become life threatening, at which point valve replacement is usually the recommended treatment option.

Depending on a person’s age and stage of disease as well as other determining factors, the standard for treatment has been surgical aortic valve replacement (SAVR), which involves open-chest surgery and replacement of the diseased valve with a bioprosthetic valve. At Lankenau our team is able to offer patients minimally invasive SAVR.

A less invasive option is transcatheter aortic valve replacement (TAVR), for people considered intermediate or high risk for surgery. Lankenau Medical Center was one of the first in the Philadelphia region to offer the procedure following FDA approval of the first TAVR device. Today we are among 10 percent of TAVR teams in the nation, performing 200 TAVR procedures per year.

Both the minimally invasive SAVR and TAVR treatment options help alleviate debilitating symptoms due to AS and improve quality of life for patients. Further, patients who receive the TAVR procedure generally have a shorter recovery time and return to daily activities more quickly.

Lankenau enrolling qualified patients for PARTNER 3 trial

As of September 2016, we are a new participant in PARTNER 3, the first ever U.S. clinical trial involving TAVR in patients with severe aortic stenosis who are at low risk for traditional surgery. The goal of the study is to show that TAVR results are comparable to SAVR in low-risk surgical patients.

We are now accepting qualified study patients. If you have severe aortic stenosis and are deemed low risk for surgery, you may qualify for this TAVR study. Eligible study participants will be randomized (1:1) to TAVR or SAVR. At Lankenau Medical Center, a study participant who is randomized to SAVR will be evaluated for and, if a candidate, offered minimally invasive SAVR.

There is extensive inclusion and exclusion criteria for this trial and as with any medical procedure, there are certain risks.